TALAZOPARIB TOSYLATE - Generic Drug Details
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What are the generic drug sources for talazoparib tosylate and what is the scope of freedom to operate?
Talazoparib tosylate
is the generic ingredient in one branded drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Talazoparib tosylate has ninety-five patent family members in thirty-one countries.
Two suppliers are listed for this compound.
Summary for TALAZOPARIB TOSYLATE
| International Patents: | 95 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| Clinical Trials: | 10 |
| Patent Applications: | 95 |
| DailyMed Link: | TALAZOPARIB TOSYLATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TALAZOPARIB TOSYLATE
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TALAZOPARIB TOSYLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Stanford University | Phase 2 |
| Roswell Park Cancer Institute | Phase 1 |
| Pfizer | Phase 1 |
Pharmacology for TALAZOPARIB TOSYLATE
| Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for TALAZOPARIB TOSYLATE
US Patents and Regulatory Information for TALAZOPARIB TOSYLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 217439-001 | Mar 7, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 217439-006 | Mar 7, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 211651-003 | Sep 20, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 211651-003 | Sep 20, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 217439-004 | Mar 7, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 217439-001 | Mar 7, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 217439-004 | Mar 7, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TALAZOPARIB TOSYLATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| United Kingdom | 2462361 | Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) activity | ⤷ Sign Up |
| Taiwan | I643858 | ⤷ Sign Up | |
| Lithuania | C2767537 | ⤷ Sign Up | |
| Taiwan | I557123 | ⤷ Sign Up | |
| China | 103282365 | Crystalline (8S,9R)--fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2012054698 | ⤷ Sign Up | |
| Poland | 2326650 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TALAZOPARIB TOSYLATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2767537 | C201930072 | Spain | ⤷ Sign Up | PRODUCT NAME: TALAZOPARIB, OPCIONALMENTE EN FORMA DE SAL FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1377; DATE OF AUTHORISATION: 20190620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1377; DATE OF FIRST AUTHORISATION IN EEA: 20190620 |
| 2767537 | 2019/060 | Ireland | ⤷ Sign Up | PRODUCT NAME: TALAZOPARIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; NAT REGISTRATION NO/DATE: EU/1/19/1377/001 EU/1/19/1377/006 20190620; FIRST REGISTRATION NO/DATE: EU/1/19/1377/001 EU/1/19/1377/006 20190620 (20200708) |
| 2767537 | 122019000108 | Germany | ⤷ Sign Up | PRODUCT NAME: TALAZOPARIB ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1377 20190620 |
| 2767537 | 132019000000153 | Italy | ⤷ Sign Up | PRODUCT NAME: TALAZOPARIB(TALZENNA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1377, 20190624 |
| 2767537 | 301021 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TALAZOPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1377 20190624 |
| 2767537 | SPC/GB19/070 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TALAZOPARIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, SUCH AS THE TOSYLATE SALT; REGISTERED: UK EU/1/19/1377 (NI) 20190624; UK PLGB00057-1672 20190624; UK PLGB00057-1673 20190624 |
| 2767537 | PA2019522 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TALAZOPARIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1377 20190620 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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